A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor: Klus Pharma Inc. + Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Safety and tolerability
Time frame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
ORR
Time frame: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Secondary Endpoints
Duration of response (DOR)
Progression-free survival (PFS)
Overall survival (OS)
Eligibility Criteria
Inclusion Criteria 1. Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; 3. Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation; 4. Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment; 5. Subjects are able to provide tumor blocks or slides before the first dose of study intervention; 6. Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; 7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ei…
Read full criteria on CT.gov →✦ Analyst Commentary
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